Safety and Efficacy of a Multi-branched Thoracoabdominal Stent Graft System for Thoracoabdominal Aortic Aneurysm.

NCT05054985 | Recruiting

• 1 other identifier: XJ-TAAA-01
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm.

Conditions

Thoracoabdominal Aortic Aneurysms

Keywords

Guo's Visceral Arteries Reconstruction; Multi-branched Thoracoabdominal Stent Graft System; Thoracoabdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• Primary safety endpoint: The incidence of Major Adverse events (MAE) within 30 days after procedure.

  Major Adverse Event (MAE) was defined as all-cause death, liver failure, intestinal necrosis, kidney failure, stroke, permanent paraplegia, myocardial infarction, and respiratory failure.

  Within 30 days after procedure

• Primary efficacy endpoint: Success rate of thoracoabdominal aortic aneurysm treatment 12 months after procedure.

  Successful treatment of thoracoabdominal aortic aneurysm is a composite index that needs to meet the following indicators at the same time: Immediate technical success (immediate technical success refers to the successful delivery system to a predetermined location, the successful deployment of the system and the safe withdrawal of the delivery system from the body and no type I/III endoleak), no secondary surgical intervention related to thoracoabdominal aortic aneurysms 12 months after procedure (due to aneurysm rupture, continuous enlargement, stent displacement, type I/III endoleak, branch stenosis/ Second surgery caused by occlusion) .

  12 months after procedure.

Secondary Outcomes (10)

• aneurysmal enlargement at 6 and 12 months postoperatively

  6 and 12 months postoperatively

• type I/III endoleak at 6 and 12 months postoperatively

  6 and 12 months postoperatively

• stent graft migration at 6 and 12 months postoperatively

  6 and 12 months postoperatively

• renovisceral artery patency rate at 6 and 12 months postoperatively

  6 and 12 months postoperatively

• reintervention secondary to TAAA progression at 6 months, 12 months, and 2-5 years postoperatively.

  6 months, 12 months, and 2-5 years postoperatively.

Study Arms (1)

Intervention arm

EXPERIMENTAL

Patients with thoracoabdominal aortic aneurysms, and passed the screening and signed the informed consent form.

Device: Multi-Branched Thoracoabdominal Stent Graft System

Interventions

Multi-Branched Thoracoabdominal Stent Graft System DEVICE

Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with multi-branched thoracoabdominal stent graft system .

Intervention arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old ≤ age ≤ 80 years old;
• Diagnosed as thoracoabdominal aortic aneurysm (based on modified Crawford classification and 2019 European Guidelines for the Treatment of Aortic aneurysm) and should meet at least one of the following conditions;
• Maximum diameter of thoracoabdominal aortic aneurysm\>50mm;
• The diameter has increased by more than 5mm in recent 6 months or the by more than 10mm in recent 1 year;
• anatomical criteria
• The proximal anchoring region (aorta or implanted graft) was 17\~36 mm in diameter and ≥25 mm in length;
• Distal anchoring region (aorta or implanted graft): If the distal anchoring region is in the iliac artery, the anchoring region has a diameter range of 7\~25 mm and a length of ≥15 mm; If the distal anchoring area is in the abdominal aorta, the diameter of the anchoring area ranges from 12\~36mm and the length≥ 20mm;
• The diameter of the vessel anchoring area of the visceral branch ranges from 6\~13 mm and the length ≥15 mm;
• The diameter of renal artery anchoring area ranges from 4.5\~9mm, and the length ≥15 mm;
• Appropriate iliac, femoral and upper limb artery access;
• Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent, and are willing to complete the follow-up according to the requirements of the protocol;

You may not qualify if:

• Hemodynamically unstable patients with ruptured thoracoabdominal aortic aneurysms;
• Thoracoabdominal aortic dissection;
• Mycotic or infectious thoracoabdominal aortic aneurysm;
• Patients whose systemic or local infection may increase the risk of intravascular graft infection;
• Superior mesenteric, celiac, or renal artery occlusion;
• Requiring simultaneous coverage and embolization of bilateral internal iliac arteries;
• Severe stenosis, calcification, or mural thrombus in the anchoring area of the stent tend to have difficulty in attachment of the stent-graft or affect the patency of the stent;
• A history of acute coronary syndrome within 6 months; Acute coronary syndrome is defined as an acute ischemic syndrome of the heart resulting from the rupture or erosion of unstable intracoronary atherosclerotic plaques followed by fresh thrombosis, including ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, and unstable angina pectoris.
• Transient ischemic attack (TIA) or ischemic/haemorrhagic stroke within 3 months;
• Preoperative liver renal function abnormalities (ALT or AST ≥ 5 times the upper limit of normal value), or serum creatinine ≥ 150 μmol/L;
• Severe pulmonary insufficiency who cannot tolerate general anaesthesia;
• Severe coagulation dysfunction;
• Undergone major surgical or interventionic surgery within 30 days before surgery;
• A history of allergy to contrast agents, anticoagulants, antiplatelet drugs, stents, and conveyor materials (nitinol, polyester, PTFE, nylon);
• Connective tissue diseases such as systemic lupus erythematosus, Marfan's syndrome, Adam's syndrome, or Behcet's disease;

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (1)

• Ge Y, Zhang H, Rong D, Liu F, Jia X, Xiong J, Ma X, Wang L, Fan T, Guo W. Protocol for GUo's renovisceral Artery reconstruction-1: a prospective, multicentre, single-arm clinical trial to evaluate the safety and efficacy of a multibRANched sTEnt graft systEm for thoracoabdominal aortic aneurysm (GUARANTEE study). BMJ Open. 2022 Mar 23;12(3):e059401. doi: 10.1136/bmjopen-2021-059401.

  PMID: 35321900 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Wei Guo, Professor

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Guo, Professor

CONTACT

13910758706; pla301dml@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 23, 2021
• Study Start: November 12, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)